Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5460](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5460) → DAD — Haptoglobin, Antigen, Antiserum, Control # DAD · Haptoglobin, Antigen, Antiserum, Control _Immunology · 21 CFR 866.5460 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD ## Overview - **Product Code:** DAD - **Device Name:** Haptoglobin, Antigen, Antiserum, Control - **Regulation:** [21 CFR 866.5460](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5460) - **Device Class:** 2 - **Review Panel:** [Immunology](/submissions/IM) ## Identification A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases. ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9. ## Recent Cleared Devices (18 of 18) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K993480](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K993480.md) | K-ASSAY HAPTOGLOBIN | Kamiya Biomedical Co. | Nov 24, 1999 | SESE | | [K972639](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K972639.md) | TINA-QUANT HAPTOGLOBIN | Boehringer Mannheim Corp. | Jan 9, 1998 | SESE | | [K964301](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K964301.md) | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | Jul 14, 1997 | SESE | | [K963286](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K963286.md) | IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT | Beckman Instruments, Inc. | Oct 7, 1996 | SESE | | [K952593](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K952593.md) | N/T PROTEIN CONTROL SY/L, M AND H | Behring Diagnostics, Inc. | Jul 17, 1995 | SESE | | [K915829](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K915829.md) | IL TEST(TM) HAPTOGLOBIN (HPT) | Instrumentation Laboratory CO | Jul 29, 1992 | SESE | | [K911898](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K911898.md) | RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT | Reagents Applications, Inc. | May 8, 1991 | SESE | | [K890562](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K890562.md) | SPQ(TM) ANTIBODY REAGENT SET II FOR HPT | Atlantic Antibodies | Feb 22, 1989 | SESE | | [K873866](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K873866.md) | HAPTOGLOBIN | Unipath , Ltd. | Oct 20, 1987 | SESE | | [K872717](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K872717.md) | QM300 HAPTOGLOBIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | Jul 21, 1987 | SESE | | [K864512](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K864512.md) | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO | Cooper Biomedical, Inc. | Feb 13, 1987 | SESE | | [K850584](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K850584.md) | SPQ TEST SYSTEM FOR HAPTOGLOBIN | Applications Lab | Mar 5, 1985 | SESE | | [K840404](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K840404.md) | DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO | Tago, Inc. | Mar 9, 1984 | SESE | | [K831957](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K831957.md) | DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB | Kent Laboratories, Inc. | Jul 18, 1983 | SESE | | [K812494](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K812494.md) | IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTO | Dako Corp. | Sep 23, 1981 | SESE | | [K801433](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K801433.md) | HAPTOGLOBIN NEPHELOMETRIC ASSAY | J.T. Baker Chemical Co. | Jul 8, 1980 | SESE | | [K772245](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K772245.md) | HAPTOGLOBIN NEPHELOMETRIC ASSAY | Kallestad Laboratories, Inc. | Dec 22, 1977 | SESE | | [K760144](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD/K760144.md) | SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID | Oxford Laboratories, Inc. | Jul 20, 1976 | SESE | ## Top Applicants - Unipath , Ltd. — 1 clearance - Tago, Inc. — 1 clearance - Reagents Applications, Inc. — 1 clearance - Oxford Laboratories, Inc. — 1 clearance - Kent Laboratories, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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